EDA
The article outlines the key points associated with the testing medical devices should undergo in order to be allowed for marketing and use in Egypt.
EDA
The new article provides further clarifications on the applicable classification system, as well as testing requirements to be considered.
EDA
The new article explains the approach to be applied with respect to clinical investigations.
EDA
The new article provides further clarifications regarding the design of a clinical study, as well as the risk management approach to be followed.
EDA
The new article pays special attention to combination products as a separate category of medical devices, and also highlights the key points related to ethical considerations.
EDA
The new article explains in detail the approach to be followed with respect to safety reporting in the context of clinical investigations conducted in order to assess the safety and effectiveness of medical devices intended to be marketed and used in Egypt.
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